A trial of HMBD-001 for solid cancers that have spread
Cancer type:
Status:
Phase:
This trial is looking at a new drug called HMBD-001 for 
that have spread into the surrounding tissue or to another part of the body.
The trial is for people who can’t have standard treatment or there isn’t a standard treatment option available.
It was open to people with several different cancer types. At the moment it is only open to people who have prostate cancer.
Cancer Research UK supports this trial.
More about this trial
Cancer that has spread is called . Researchers think that HMBD-001 might help people with certain types of advanced cancer.
HMBD-001 is a type of called a monoclonal antibody. It works by finding a protein on cancer cells called HER3. This protein is found in high numbers on some cancer cells. HMBD-001 attaches to the HER3 protein. This blocks the signals that cancer cells use to divide and grow. Researchers think this may slow cancer growth.
There are 2 parts to this trial. In the first part the team looked at finding the best dose of HMBD-001. This is a dose escalation study. This part of the trial is now closed.
In part 2, the team are looking at how well HMBD-001 works in combination with a drug called enzalutamide. It is a standard for prostate cancer. Part 2 is open for people to join.
The main aims of this trial are to find out:
- the best dose of HMBD-001 to give
- more about the side effects
- what happens to HMBD-001 in the body
- how well HMBD-001 works on its own or in combination with other cancer drugs
Who can enter
The following bullet points are a summary of the entry conditions for people having HMBD-001 on its own.
Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
Dose escalation (part A) - please note, this part of the trial is now closed to recruitment
This part was for people with several different cancer types.
Dose expansion (part B, group 1) - open to recruitment
To join the second part of the trial you must have one of the following cancer types:
- prostate cancer that has got worse despite having hormone treatment
- have low levels of the hormone testosterone in the blood. And you must have had abiraterone, enzalutamide, apalutamide or darolutamide in the past.
- have a PSA level that is more than 1ng/ml
- have high levels of the HER3 protein on your cancer cells or another particular gene change that the trial team will look for called NRG1 gene fusion
- have cancer that has PTEN in the prostate cancer cells
- are willing to give a new sample of tissue for the trial team to do some tests on or there is a sample of tissue the team can access. This is to check for HER3 and PTEN. You must be willing to give a sample if there isn’t one available or if it was taken more than 2 years ago.
- have satisfactory blood test results
- are fit and able to look after yourself but might not be able to do heavy physical work (performance status 0 or 1)
- are willing to use reliable contraception during the trial and for a period after if there is any chance your partner could become pregnant
- are at least 18 years old
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
- have had chemotherapy,
hormone therapy (unless it was a drug called a luteinising hormone releasing hormone (LHRH) for prostate cancer), immunotherapy , an experimental drug or radiotherapy within 4 weeks of starting trial treatment. You may be able to take part if you had radiotherapy to help cancer symptoms (palliative treatment). - have cancer that has spread to the brain or spinal cord unless it isn’t causing symptoms, has been treated and is stable
- have side effects from past treatments unless they are mild. This is apart from hair loss or moderate numbness and tingling in the hands or feet (
peripheral neuropathy ). - are taking part or plan to take part in another clinical trial using an experimental treatment. You may be able to join a non treatment trial.
Medical conditions
You cannot join this trial if any of these apply. You:
- have had a reaction to a targeted drug in the past
- have had major surgery and you aren’t fully better
- have HIV, hepatitis B, an active hepatitis C infection or any other severe active infection that isn’t well controlled with medication
- have had a heart attack,
angina or surgery to repair a blocked artery in your heart in the last 6 months. You can’t take part if your heart doesn’t work well or you have another significant heart problem that needs treatment. The trial team check if you have a heart condition before you join the trial. - have an
autoimmune condition that needs treatment apart from certain ones. Your doctor will know about this. - have had treatment that damps down the
immune system . This includes steroids within one week of starting trial treatment unless it was a low dose. - are taking medication to thin the blood, for example warfarin
- have fits (seizures) or you are at risk of this happening. Your doctor will know this.
- have or have had another cancer that your doctor thinks will affect you taking part. You may be able to take part if you have had
non melanoma skin cancer , early bladder cancers or very early cancers (carcinoma in situ or CIS) that has been successfully treated. - have another medical condition that your doctor or the trial team think could affect you taking part
Other
You cannot join this trial if any of these apply. You:
- are allergic to enzalutamide or anything it contains
- have had enzalutamide or a similar drug in the past and you had to stop taking it due to side effects or you had a lower dose due to side effects
- have had a live
vaccine within 4 weeks of having the first dose of HMBD-001. This doesn’t include COVID-19 vaccines as these are not live vaccines.
Trial design
This is a phase 1/2 trial. There are 2 parts to this trial:
- dose escalation (part A) – closed
- dose expansion (part B) – open
In total the team need up to 81 people across the UK to take part. This includes 30 people who have prostate cancer.
You have HMBD-001 as a drip into a vein once a week. Enzalutamide is a tablet. You take it once a day, every day.
You have . Each cycle is 4 weeks. You have up to 6 cycles of treatment. You might continue to have enzalutamide only if your cancer hasn't got worse.
You stop treatment if your cancer gets worse. Your doctor will talk to you about other treatment options.
Dose escalation (part A) – closed
The first few people taking part had a low dose of HMBD-001. The next few people had a higher dose if they didn't have serious side effects. And so on, until the doctor found the best dose.
Dose expansion (part B, group 1 for prostate) – open
In part B you have HMBD-001 and enzalutamide. You have the best dose of HMBD-001 they found in part A.
Research samples
You have some extra blood samples taken when you have treatment. The team can tell you exactly when you give these. Where possible you have them at the same time as your routine blood tests. Researchers will use these samples to:
- find out what happens to HMBD-001 in the body
- check how HMBD-001 is working
- look for
biomarkers
Depending on when you enter the trial, your trial doctor may also ask you to give another tissue sample. This is to look at your and to try to see why treatment works well for some and not others. They ask to collect these samples at 2 different timepoints.
You don’t have to agree to give these extra tissue samples if you don’t want to. You can still take part in the rest of the trial.
Hospital visits
You see the doctor and have tests before you can take part. These include:
- blood tests
- a
physical examination - heart trace (
ECG ) - heart scan (
echocardiogram ) or MUGA scan - CT scan or MRI scan
You have HMBD-001 at hospital in the day care unit. You’ll be in hospital for most of the day for treatment visits in the first 2 cycles. After that, each visit takes about half a day.
You may stay overnight in hospital after your first dose. This is so they can monitor you for any side effects.
You see the doctor during treatment at regular times. This is to see how you are and for some tests.
During treatment you have a CT or MRI scan every 8 to 12 weeks.
When you stop treatment you see the trial team a month later. After that, they check your medical notes to see how you are. And to find out if you have started another cancer treatment.
Side effects
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
HMBD-001 is a new drug. This is the first time that people are having HMBD-001 in combination with enzalutamide so we don’t know about all the side effects.
The possible side effects we know about so far include:
- feeling or being sick
- diarrhoea
- changes to your heartbeat
- changes to the levels of magnesium or potassium in your blood
- a drop in
red blood cells causing tiredness and breathlessness - liver changes
- skin rash
- tiredness (fatigue)
- fertility problems
You might have an allergic reaction while having HMBD-001 or shortly after. These symptoms could include shivering, a skin rash or shortness of breath and chills. You may have drugs just before having HMBD-001 to reduce the risk of this happening. The nurse and doctor keep a close eye on you during and after the HMB-001 treatment. They will treat any problems straight away.
We have information about enzalutamide and its side effects.
Taking other medications
While you are taking part in the trial you should not start any new doses of steroids unless your trial doctor asks you to. You should let your trial nurse or doctor know about any medication you are taking. This includes any herbal or vitamin supplements or drugs you buy over the counter at chemists and supermarkets.
Location
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Johann de Bono
Supported by
Cancer Research UK (Centre for Drug Development)
Other information
This is Cancer Research UK trial number CRUKD/22/002.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
